Labs IT Systems Deployment and Support Technical Lead

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve.

This is hard, urgent, selfless work—this is work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Lilly is entering an exciting period of growth and we are committed to delivering innovative medicines to patients around the world. Lilly is investing over $3 Billion to create a new state‑of‑the‑art manufacturing site for Drug Substance, in Lebanon, Indiana. The brand‑new facility will utilize a variety of Platforms and have the latest technology for API Manufacturing and Technology. This is an exciting once‑in‑a‑lifetime opportunity to help build and operate a new site.

The Lilly Lebanon API Manufacturing site will be built using the latest high‑tech equipment, advanced highly integrated and automated manufacturing systems, and have a focus on minimizing the impact to our environment.

You will be part of Technology at Lilly MQ (Manufacturing and Quality), an organization that drives manufacturing operational excellence and productivity efforts through utilization of technology. Technology at Lilly MQ strives to enable the making of medicine “with safety first and quality always”. As a Lab CSV and Compliance Analyst, you will ensure the manufacturing Labs systems (MODA, Lab Vantage, NuGenesis, Empower, WInKQCL, etc.)

and computerized lab instruments are deployed with proper and right‑sized validation documents e systems and instruments are deployed, this role will evolve into monitoring, execution, and maintenance of the Laboratory IT Systems and Instruments, with an emphasis on continuous improvement, especially with regards to data integrity. This role will harness a deep understanding of CSV and Data Integrity principles ensuring compliance with regulatory requirements, consistent application, and sustainability for local and global Technology at Lilly systems, and labs instruments used at the LP1 site.

This role will collaborate with the local and global Computer System Quality Assurance team and Technology at Lilly organization to enable best practices, processes, and governance to consider new points to strengthen the Technology at Lilly CSV and Data Integrity position and align with corporate objectives and initiatives.

• Lead and/or support the laboratory with the validation of laboratory equipment and software systems including computerized analytical instrument qualification (IQ/OQ/PQ) and computerized system validation across GAMP 5 software categories.
• Support the establishment and maintenance of the validated state of software‑based computerized systems and lab instruments in use in the lab, including ownership of periodic review cycles to confirm ongoing compliance and fitness for intended use.
• Partner cross‑functionally with site DI SMEs to ensure a common, systematic approach to meeting existing and new DI/CSV expectations. This includes, but is not limited to, audit trail management, workstation security, and connecting stand‑alone equipment.
• Support site deployment and upgrade of laboratory IT systems such as MODA, Empower, NuGenesis, and Lab Vantage with any CSV needs.
• Partner and establish relationships with Global Quality Laboratory Network, Global and Site IT team members, Computer System Quality Assurance, site Quality Assurance, and external vendor/supplier organizations.
• Provide oversight and support continuous improvement of systems/instruments as they relate to the labs.
• Apply knowledge of quality principles, cGMP, and laboratory systems towards the development and execution of local procedures, training courses, and practices.
• Manage and support both internal or external…